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Ondansetron Oral Dissolve Tab vs. Oral Solution in Children Presenting to the Emergency Department with
Graham C Thompson1, Ellen L Morrison2, David Chaulk3
1Department of Pediatrics, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.
Insights
Ondansetron oral dissolve tab (ODT) showed a trend toward less early vomiting in children with acute gastroenteritis (AGE) compared to oral solution (OS). Intravenous fluid administration rates were similar between groups.
Area of Science:
- Pediatric Emergency Medicine
- Pharmacology
- Gastroenterology
Background:
- Ondansetron is frequently used in emergency departments (ED) for acute gastroenteritis (AGE) in children to facilitate oral rehydration.
- Oral medication formulations can be poorly tolerated by pediatric patients.
Purpose of the Study:
- To compare the tolerability of ondansetron oral dissolve tab (ODT) versus oral solution (OS) in children with AGE presenting to the ED.
- To evaluate early vomiting and the need for intravenous (i.v.) fluid administration as primary and secondary outcomes.
Main Methods:
- An alternate-day controlled clinical trial was conducted with children aged 3 months to 10 years.
- Participants received either ondansetron ODT or OS.
- Primary outcome: early vomiting within 15 minutes of administration. Secondary outcome: i.v. fluid administration.
Main Results:
- In intention-to-treat analysis, early vomiting occurred in 3.8% of ODT recipients versus 7.5% of OS recipients (OR 0.49).
- As-treated analysis showed a significantly lower rate of early vomiting with ODT (2.7%) compared to OS (9.5%) (OR 0.26).
- The proportion of children discharged without i.v. fluids was similar between the ODT and OS groups in both intention-to-treat and as-treated analyses.
Conclusions:
- While intention-to-treat analysis did not show a statistically significant reduction in early vomiting with ondansetron ODT compared to OS, as-treated analysis suggested a substantial decrease.
- Ondansetron ODT may be a better tolerated alternative to OS in pediatric AGE patients.
- Neither formulation impacted the need for i.v. fluid administration.
Background:
Ondansetron is often used in the emergency department (ED) to promote oral rehydration in children with acute gastroenteritis (AGE), yet medication solutions administered orally may be poorly tolerated in this population.
Objectives:
We compared the tolerability of ondansetron oral dissolve tab (ODT) to oral solution (OS) in children presenting to the ED with AGE.
Methods:
Using alternate-day controlled clinical trial design, children aged 3 months to 10 years received either ondansetron ODT or OS. Our primary outcome was early vomiting (within 15 min of drug administration). The secondary outcome was intravenous (i.v.) fluid administration.
Results:
There were 462/534 eligible children who met study criteria. Demographics, severity, and duration of illness were similar between groups. Using intention-to-treat analysis, early vomiting occurred in 8/209 ODT vs. 19/253 OS children (3.8% vs. 7.5%; odds ratio [OR] 0.49; 95% confidence interval [CI] 0.18-1.21). Using as-treated analysis, 6/222 (2.7%) children receiving ODT experienced early vomiting, compared with 21/221 (9.5%) of the OS group (OR 0.26; 95% CI 0.09-0.70). The proportion of children discharged without i.v. fluids was not different (intention-to-treat: ODT = 91.4% (191/209), OS = 94.1% (238/253), OR 1.49, 95% CI 0.69-3.28; as-treated: ODT = 92.3% (205/222), OS = 93.2% (206/221), OR 0.88, 95% CI 0.40-1.93).
Conclusions:
Using a conservative intention-to-treat analysis, we found that children presenting to an ED with AGE did not have statistically less early vomiting with ondansetron ODT as compared with OS. However, our as-treated analysis demonstrates that children receiving ondansetron ODT experienced early vomiting approximately one-third as often as those receiving OS. The rate of i.v. fluid administration was no different between groups regardless of the type of analysis used.
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